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WO2009111998A3 - Specific impurities of montelukast - Google Patents

Specific impurities of montelukast Download PDF

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Publication number
WO2009111998A3
WO2009111998A3 PCT/CZ2009/000038 CZ2009000038W WO2009111998A3 WO 2009111998 A3 WO2009111998 A3 WO 2009111998A3 CZ 2009000038 W CZ2009000038 W CZ 2009000038W WO 2009111998 A3 WO2009111998 A3 WO 2009111998A3
Authority
WO
WIPO (PCT)
Prior art keywords
montelukast
specific impurities
substance
impurities
xiiib
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CZ2009/000038
Other languages
French (fr)
Other versions
WO2009111998A2 (en
Inventor
Ales Halama
Olga Bouskova
Petr Gibala
Josef Jirman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Zentiva KS
Original Assignee
Zentiva KS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Zentiva KS filed Critical Zentiva KS
Priority to EA201001395A priority Critical patent/EA201001395A1/en
Priority to US12/922,267 priority patent/US20110034692A1/en
Priority to EP09719540A priority patent/EP2260025A2/en
Publication of WO2009111998A2 publication Critical patent/WO2009111998A2/en
Publication of WO2009111998A3 publication Critical patent/WO2009111998A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D215/00—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems
    • C07D215/02—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom
    • C07D215/16—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
    • C07D215/18—Halogen atoms or nitro radicals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D405/00—Heterocyclic compounds containing both one or more hetero rings having oxygen atoms as the only ring hetero atoms, and one or more rings having nitrogen as the only ring hetero atom
    • C07D405/02—Heterocyclic compounds containing both one or more hetero rings having oxygen atoms as the only ring hetero atoms, and one or more rings having nitrogen as the only ring hetero atom containing two hetero rings
    • C07D405/10—Heterocyclic compounds containing both one or more hetero rings having oxygen atoms as the only ring hetero atoms, and one or more rings having nitrogen as the only ring hetero atom containing two hetero rings linked by a carbon chain containing aromatic rings

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pulmonology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Immunology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Quinoline Compounds (AREA)

Abstract

The subject-matter of the invention consists in a method of removing specific impurities of montelukast of formula (I), which occur due to chemical instability of the target substance and also contaminate the substance in the preparation process. Further, methods of isolation of specific impurities of montelukast defined by formulae (V-A), (IV-A), (XIIIa-A), (XIIIb-A) and analytic methods used for the control of the production of montelukast in the pharmaceutical quality.
PCT/CZ2009/000038 2008-03-14 2009-03-11 Specific impurities of montelukast Ceased WO2009111998A2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EA201001395A EA201001395A1 (en) 2008-03-14 2009-03-11 SPECIFIC IMPURITIES OF MONTELUKAST
US12/922,267 US20110034692A1 (en) 2008-03-14 2009-03-11 Specific impurities of montelukast
EP09719540A EP2260025A2 (en) 2008-03-14 2009-03-11 Specific impurities of montelukast

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CZPV2008-167 2008-03-14
CZ20080167A CZ2008167A3 (en) 2008-03-14 2008-03-14 Montelucast specific impurities

Publications (2)

Publication Number Publication Date
WO2009111998A2 WO2009111998A2 (en) 2009-09-17
WO2009111998A3 true WO2009111998A3 (en) 2010-03-25

Family

ID=40750936

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CZ2009/000038 Ceased WO2009111998A2 (en) 2008-03-14 2009-03-11 Specific impurities of montelukast

Country Status (5)

Country Link
US (1) US20110034692A1 (en)
EP (1) EP2260025A2 (en)
CZ (1) CZ2008167A3 (en)
EA (1) EA201001395A1 (en)
WO (1) WO2009111998A2 (en)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2288595B1 (en) * 2008-05-26 2016-11-02 Laurus Labs Private Limited An improved process for preparing montelukast and salts thereof
AU2009305214B2 (en) 2008-10-15 2015-06-25 Generics [Uk] Limited Process for the preparation of vorinostat
JP2012509929A (en) 2008-11-26 2012-04-26 ジェネリクス・（ユーケー）・リミテッド Polymorphism
WO2011061545A1 (en) * 2009-11-23 2011-05-26 Generics [Uk] Limited Hplc method for analyzing vorinostat
US8471030B2 (en) 2010-12-06 2013-06-25 Orochem Technologies Inc. Purification of montelukast using simulated moving bed
CN102060762B (en) * 2011-01-28 2013-05-29 海南美大制药有限公司 Montelukast compound and new preparation method thereof
JP5553096B2 (en) * 2012-08-29 2014-07-16 大日本印刷株式会社 Manufacturing method of high purity montelukast
JP6162004B2 (en) * 2013-09-10 2017-07-12 株式会社トクヤマ Montelukast Sodium Intermediate Analysis Method
CN105924392B (en) * 2016-02-29 2018-03-02 山东新时代药业有限公司 A kind of Menglusitena preparation method
CN105585524B (en) * 2016-02-29 2018-03-02 山东新时代药业有限公司 A kind of method that Menglusitena is prepared by montelukast acid
CN110045049B (en) * 2018-01-17 2021-07-09 天津药物研究院有限公司 Method for simultaneously determining various related substances of montelukast sodium and preparation thereof
CN109900823A (en) * 2019-03-12 2019-06-18 康诚科瑞医药研发（武汉）有限公司 The quantitative detecting method of montelukast in a kind of human plasma

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050107612A1 (en) * 2002-12-30 2005-05-19 Dr. Reddy's Laboratories Limited Process for preparation of montelukast and its salts
WO2006008751A2 (en) * 2004-07-19 2006-01-26 Matrix Laboratories Ltd Process for the preparation of montelukast and its salts
WO2006043846A1 (en) * 2004-10-22 2006-04-27 Instytut Farmaceutyczny Salt of montelukast with tert.-butylamine
WO2007072114A1 (en) * 2005-12-23 2007-06-28 Glade Organics Private Limited An improved process for the manufacture of montelukast sodium
WO2007107297A1 (en) * 2006-03-17 2007-09-27 Synthon B.V. Montelukast amantadine salt

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7189853B2 (en) * 2004-04-15 2007-03-13 Dr. Reddy's Laboratories Limited Process for the preparation of [R-(E)-1-[[[1-[3-[2-[7-chloro-2-quinolinyl]ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid (Montelukast) and its pharmaceutically acceptable salts
KR20080105070A (en) * 2006-02-21 2008-12-03 케마지스 리미티드 Novel Polymorphs of Montelukast Ammonium Salts and Methods for Making the Same
IL181607A0 (en) * 2006-02-27 2007-07-04 Chemagis Ltd Novel process for preparing montelukast and salts thereof

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050107612A1 (en) * 2002-12-30 2005-05-19 Dr. Reddy's Laboratories Limited Process for preparation of montelukast and its salts
WO2006008751A2 (en) * 2004-07-19 2006-01-26 Matrix Laboratories Ltd Process for the preparation of montelukast and its salts
WO2006043846A1 (en) * 2004-10-22 2006-04-27 Instytut Farmaceutyczny Salt of montelukast with tert.-butylamine
WO2007072114A1 (en) * 2005-12-23 2007-06-28 Glade Organics Private Limited An improved process for the manufacture of montelukast sodium
WO2007107297A1 (en) * 2006-03-17 2007-09-27 Synthon B.V. Montelukast amantadine salt

Non-Patent Citations (7)

* Cited by examiner, † Cited by third party
Title
"An improved process to obtain Montelukast sodium", RESEARCH DISCLOSURE, MASON PUBLICATIONS, HAMPSHIRE, GB, vol. 521, no. 2, 1 September 2007 (2007-09-01), pages 908, XP007137576, ISSN: 0374-4353 *
"Piperazine salts of Montelukast, a new efficient method of purification", IP.COM JOURNAL, IP.COM INC., WEST HENRIETTA, NY, US, 29 November 2007 (2007-11-29), XP013122974, ISSN: 1533-0001 *
AL OMARI ET AL: "Effect of light and heat on the stability of montelukast in solution and in its solid state", JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, NEW YORK, NY, US, vol. 45, no. 3, 19 October 2007 (2007-10-19), pages 465 - 471, XP022306740, ISSN: 0731-7085 *
DUFRESNE C ET AL: "Synthesis of montelukast (MK-0476) metabolic oxidation products", JOURNAL OF ORGANIC CHEMISTRY, AMERICAN CHEMICAL SOCIETY, EASTON.; US, vol. 61, no. 24, 1 January 1996 (1996-01-01), pages 8518 - 8525, XP002284162, ISSN: 0022-3263 *
GRAUL L ET AL: "Montelukast sodium, MK-476, MK-0476, L-706631, Singulair", DRUGS OF THE FUTURE, PROUS SCIENCE, ES, vol. 22, no. 10, 1 January 1997 (1997-01-01), pages 1103, XP008082254, ISSN: 0377-8282 *
NELSON ERIC D ET AL: "Evaluation of solution oxygenation requirements for azonitrile-based oxidative forced degradation studies of pharmaceutical compounds.", July 2006, JOURNAL OF PHARMACEUTICAL SCIENCES JUL 2006, VOL. 95, NR. 7, PAGE(S) 1527 - 1539, ISSN: 0022-3549, XP002563008 *
SMITH GLENN A ET AL: "An automated method for the determination of montelukast in human plasma using dual-column HPLC analysis and peak height summation of the parent compound and its photodegradation product.", September 2004, PHARMACEUTICAL RESEARCH SEP 2004, VOL. 21, NR. 9, PAGE(S) 1539 - 1544, ISSN: 0724-8741, XP002563007 *

Also Published As

Publication number Publication date
EA201001395A1 (en) 2011-02-28
CZ2008167A3 (en) 2010-02-24
WO2009111998A2 (en) 2009-09-17
US20110034692A1 (en) 2011-02-10
EP2260025A2 (en) 2010-12-15

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